Many compounds have been described for use on the skin and mucous membranes for various purposes. In U.S. Pat. No. 5,236,699, a formulation of triclosan and a cationic compound is described as being useful as an antiplaque mouth rinse and for other purposes. Generally, for treating solutions to be acceptable, they must be clear solutions that are stable. If these solutions form a precipitate upon standing at ambient conditions, it will not be acceptable to patients. The formulations of U.S. Pat. No. 5,236,699 are made using a solubilizer and alcohol to provide a stable clear solution of triclosan and a cationic antimicrobial compound. The concentration of triclosan in U.S. Pat. No. 5,236,699 is described at col. 3, lines 50-51 as being about 0.01 to 0.05% by weight. Due to the limited solubility of triclosan in water, a combination of ethyl alcohol and a solubilizer is used to achieve a stable and clear solution.
The presence of as little as 3-10% by weight of ethyl alcohol can cause tissue irritation, a burning sensation or drying of the skin or the mucosa. The presence of ethyl alcohol in formulations is unacceptable for various patient groups including those with alcohol dependencies, liver dysfunction, and other metabolic disorders.
It has been found that when propylene glycol is used to dissolve the flavor components, this will contribute to the tendency of the solution to become cloudy.
The use of solubilizers such as polysorbate 80 has been shown to inactivate triclosan and higher amounts of ethyl alcohol will increase the potential for problems with irritation and burning.
The applicant has found that use of a non-toxic polyhydric alcohol in combination with a polyoxy-alkylene and water will provide a stable triclosan solution where the concentration of triclosan may be up to 3% by weight.
Accordingly it is a primary object of this invention to provide a stable solution of triclosan.
It is also an object of this invention to provide a solution of triclosan without the use of ethyl alcohol.
It is also an object of this invention to provide a stable solution of triclosan having a triclosan content of up to 3% by weight.
These and other objects of the invention will become apparent from a review of the appended disclosure.